Half-Year 2022 Financial and Clinical Trials Update
Lunsumio (mosunetuzumab, CD20 x CD3, RG7828)
Bispecific anti-CD20/CD3 antibody engaging T and B cells simultaneously
Indication
3L+ FL, 3L+ DLBCL & other relapsed or
refractory NHL
1L DLBCL
Relapsed or refractory DLBCL
Phase/study
# of patients
Design
Primary endpoint
Status
Phase I/II
N=746
■ Dose escalation study of Lunsumio as single
agent and in combination with Tecentriq
Expansion cohorts for r/r FL, r/r DLBCL and SC
in r/r NHL
"
Safety, tolerability, dose/schedule, PK and
response rates
Data in r/r NHL presented at ASH 2018 and
2019, and in r/r FL at ASH 2020 and ASH 2021
BTD granted by FDA Q2 2020
■ SC cohort FPI Q2 2021
Filed in EU and rolling submission submitted in
US Q4 2021
"
Phase Ib/II
N=160
Lunsumio plus CHOP
Lunsumio plus CHP plus Polivy
■ Lunsumio plus CHP-Polivy vs Rituximab plus
CHP-Polivy
Safety/tolerability and response
"
FPI Q1 2019
Data for Lunsumio plus CHOP presented at
ASH 2020
☐
Phase lb
N=262
▪ Lunsumio plus Polivy, randomised cohorts
ARM A: Lunsumio SC plus Polivy
- ARM B: Rituximab plus Polivy
▪ Safety/tolerability and response
FPI Q3 2018
Initial data presented at ASCO and ASH 2021
CT Identifier
☐
Approved in EU Q2 2022
-
Filed in US (priority review) Q2 2022
NCT02500407
NCT03677141
NCT03671018
FL-follicular lymphoma; DLBCL-diffuse large B cell lymphoma; r/r-relapsed/refractory; NHL-non-Hodgkin's lymphoma; R=Rituximab; SC-subcutaneous; CHOP-cyclophosphamide, doxorubicin, vincristine, and prednisone;
CHP-cyclophosphamide, doxorubicin, and prednisone); PK-Pharmacokinetics; BTD=Breakthrough Therapy Designation; ASH-American Society of Hematology; ASCO-American Society of Clinical Oncology
102
Roche
OncologyView entire presentation